Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone

Trial Information

Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways: A Phase I Trial of Docetaxel, Estramustine, Mitoxantrone and Prednisone

OBJECTIVES:

- Determine the maximum tolerated doses of docetaxel and mitoxantrone in combination with
a fixed dose of estramustine and prednisone, when given to patients with advanced
prostate cancer.

- Characterize the toxicity of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of mitoxantrone and docetaxel. Patients are
stratified into one of two risk groups (good risk group or poor risk group) based on the
number of prior chemotherapy regimen(s) and the occurrence and sites(s) of prior radiation.

All patients receive oral prednisone twice daily on days 0-3, oral estramustine three times
daily on days 1-5, mitoxantrone IV bolus on day 2, and docetaxel IV over 1 hour on day 2.
Courses repeat every 21 days in the absence of unacceptable toxicity and disease
progression. Patients with stable disease may go off treatment after 6 courses.

Dose escalation proceeds independently for each risk group. Cohorts of 3 patients are
entered into each risk group. If 1 of 3 patients at a dose level experiences dose limiting
toxicity (DLT), then 3 additional patients are accrued into this level. If 2 of 6 patients
at a dose level experience DLT, then dose escalation stops and the maximum tolerated dose
(MTD) is defined at the previous dose level. At least 6 patients must be treated at the MTD.

Patients are followed every 3 months until death.

PROJECTED ACCRUAL: At least 12 patients (6 in each risk group) will be accrued into this
study.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Failure of complete androgen ablation (orchiectomy or LHRH and antiandrogen therapy)
as manifested by at least 1 of the following criteria:

Name

Location

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